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Associate Manager, GCP Quality

Employer
Regeneron Pharmaceuticals, Inc.
Location
Basking Ridge, New Jersey
Start date
Jun 1, 2023

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

The Associate Manager GCP Quality sits within a team responsible for quality standards within the wider Global Development (GD) Quality group. The quality standards team is responsible for facilitation and support of the Quality Management System, including development of QMS health measures, support for oversight committees, and engagement and collaboration with QMS partners and leaders. The team is responsible for processes supporting Issue Management and Governance & Oversight.

A key area of focus for the Associate Manager will be supporting the deviation and CAPA processes, including support for Quality Event and Action Item Owners in the completion of risk-based activities within established due dates. We expect you will facilitate the completion of metrics and trending across the QMS, with a particular focus on Issue Management. You will also assist in the identification and implementation of continuous improvement initiatives and other projects. The Associate Manager will participate in training and change management activities supporting the QMS.

In this role, a typical day will include the following:

  • Management of the Quality Event Oversight mailbox; respond to and action end user questions and requests related to Deviations, CAPAs and Remedial Actions
  • Disseminate crucial information, project status updates, and metrics to management on assigned projects. When required, organize and support management in chairing regular and frequent project team meetings
  • Support education and/or training initiatives to other GxP functional areas as they relate to processes managed by the team e.g., root cause analysis training etc.
  • Support continuous improvement initiatives led by the team in conjunction with the business in support of the wider GD Quality group’s objectives
  • Proactively identify and lead projects to streamline, strengthen and improve processes as they relate to internal team operations (e.g., reporting, document management etc.)

This role might be for you if:
  • You worked with an electronic Quality Event Management System (preferably Veeva Quality Vault)
  • You understand the principles of Quality Risk Management, Change Management, and Issue Management as they pertain to GCP and clinical research
  • You have strong communication skills (written and verbal)
  • You are capable of project/operations management, client management, collaboration skills and negotiation of sophisticated situations
  • You have strong organizational skills including attention to detail and multi-tasking skills

To be considered for the opportunity, we expect the Associate Manager to have 3-7 years of experience within the life science industry with a focus on Quality Standards and Quality Mgmt. systems. We also expect you to be in the office a couple days a week.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$92,500.00 - $150,900.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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